drugset / Trial / NCT01019434

Radiation Therapy and Temsirolimus or Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

NCT01019434

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with temsirolimus or temozolomide in treating patients with glioblastoma. PURPOSE: This randomized phase II trial is studying giving radiation therapy together with temsirolimus to see how well it works compared with giving radiation therapy together with temozolomide in treating patients with newly diagnosed glioblastoma.

Timeline

Start
2009-10
Primary completion
2013-12
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 75 mg/m2 Oral
Subject Temsirolimus Small molecule 25 mg Intravenous